Job Summary:
The Production Associate is responsible for overseeing the preparation, dispensing, and quality compliance of buffers and reagents for nucleic acid extraction kits. The role involves hands-on manufacturing, chemical handling, process documentation in SAP, and supporting process validation activities for new product development.
Key Responsibilities:
1. Buffer & Reagent Preparation
- Independently prepare buffers and reagents for DNA/RNA extraction kits as per batch manufacturing records (BMR).
- Ensure pH, conductivity, and other specifications are met during preparation.
2. Chemical & Reagent Management
- Manage inventory and safe handling of laboratory chemicals and raw materials.
- Ensure proper labeling, MSDS availability, and storage in compliance with HSE guidelines.
3. Buffer Dispensing Operations
- Dispense prepared buffers and reagents into suitable primary containers under controlled conditions.
- Ensure accuracy, hygiene, and aseptic techniques are maintained during the process.
4. SAP Documentation – Work Orders
- Execute and close production-related work orders in SAP.
- Record real-time data for raw material consumption, batch output, and process deviations.
5. In-Process QC of Buffers & Reagents
- Perform in-process checks and basic QC validation (pH, color, clarity, etc.) before release.
- Coordinate with the QC team for sampling and release.
6. Support for New Product Validation (D&D)
- Accompany the Assistant Manager in Design & Development (D&D) activities.
- Support process validation (IQ, OQ, PQ) and scale-up for new product lines.
7. Manufacturing Line Ownership
- Take end-to-end responsibility for the extraction kit manufacturing line.
- Ensure timely completion of assigned batches and report any delays or issues.
8. Equipment Handling & Validation
- Operate and maintain production equipment (magnetic racks, filling lines, mixers, etc.).
- Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment.
Key Requirements:
- Education: B.Sc. / M.Sc./ B.Tech/ M.Tech in Biotechnology, Biochemistry, Life Sciences, or related disciplines
- Experience: 0–3 years in IVD, Biotech, or Molecular Diagnostic Kit production
Skills Required:
- Strong knowledge of buffer chemistry, sterile techniques, and reagent formulation
- Hands-on experience with SAP production modules
- Familiarity with ISO 13485, GMP, and QMS documentation
- Understanding of equipment validation (IQ/OQ/PQ)
Job Types: Full-time, Permanent
Pay: ₹25,000.00 - ₹32,000.00 per month
Benefits:
- Health insurance
- Paid sick time
- Provident Fund
Work Location: In person
